SpectronRx is a CDMO that is FDA and EMA inspected.   We are licensed to handle multiple Therapeutic and Diagnostic isotopes pharmaceutical grade including Pb-212, Lu-177, Ac-225 and I-131 for various clinical applications.  Spectron operates under a quality program that has been inspected by the FDA with approved drugs FDG, NaF and Ammonia.  Spectron provides labeling and contract manufacturing services as it relates to Lu-177, Ac-225, I-131, I-124, I-111, Zr-89, Copper-64 and Fluorine-18.

Health Care

Nuclear

Pharmaceutical

SpectronRx

SpectronRx's headquarters in Indianapolis, IN, United States

This department oversees and coordinates various projects to ensure they are completed on time and within budget.

Project Management

The Manufacturing and Production Team at SpectronRx is responsible for the production and quality control of pharmaceutical-grade therapeutic and diagnostic isotopes such as Pb-212, Lu-177, Ac-225, and I-131. This team ensures that all manufacturing processes comply with FDA and EMA regulations, manages the labeling and contract manufacturing services, and oversees the production of approved drugs like FDG, NaF, and Ammonia. Key roles include production chemists, specialists in radiopharmaceutical production, and nuclear pharmacists, all working together to maintain high standards of safety, efficiency, and regulatory compliance.

Manufacturing and Production Team

This department ensures that products meet quality standards through systematic testing and evaluation.

Quality Assurance

The Quality Control Team at SpectronRx ensures the integrity and compliance of all pharmaceutical isotopes and radiolabeling products by conducting rigorous testing and analysis according to FDA and EMA standards. This includes validating manufacturing processes, performing environmental monitoring, and maintaining high standards for product safety and efficacy. The team plays a critical role in ensuring that all therapeutic and diagnostic isotopes meet stringent quality requirements before reaching clinical settings.

Quality Control Team

The Research and Development (R&D) team at SpectronRx focuses on innovating and optimizing processes for the development and handling of therapeutic and diagnostic isotopes, such as Pb-212, Lu-177, Ac-225, and I-131. This team is responsible for advancing the company's capabilities in pharmaceutical grade isotope labeling and contract manufacturing, ensuring adherence to stringent FDA and EMA standards. Their work involves extensive experimentation, refining production methods, and collaborating closely with other departments to bring new radiopharmaceutical solutions from concept to clinical application.

Research and Development

This department oversees the production and management of nuclear pharmacy services, ensuring compliance and quality in radioactive pharmaceuticals.

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Other teams

Manufacturing and Production Team

Quality Assurance

Quality Control Team

Research and Development

Nuclear Pharmacy Management